Research Roundup: Prequalification for HCV self-test, Trial for antimalarials in pregnancy, Adjuvant boosts vaccines in mice

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. The US Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority, has awarded $176 million to Moderna to support the continued development of a pandemic influenza vaccine that could be used to treat bird flu in people, as concerns about the spread of bird flu cases in dairy cows across the United States continue to rise. Moderna's bird flu vaccine candidate is in very early-stage testing and uses the same mRNA technology as its COVID-19 vaccine. The new funding could support a late-stage trial of the vaccine candidate as early as next year if early study results continue to be positive. The vaccine could also be quickly redirected to target another form of influenza if a different threat emerges.A research team has developed a test that will help measure the persistence of HIV in people affected by viral strains found predominantly in Africa, which are greatly understudied, helping to fill a major gap in HIV research. Most HIV studies have focused on the strains circulating in Western countries, predominantly by men who have sex with men affected by subtype B, with much fewer studies examining strains circulating in Africa, where women are disproportionately affected. The new laboratory test allows researchers to determine whether following antiretroviral treatment there is any intact viral DNA capable of producing new viruses if antiretroviral treatment is interrupted. The test is already being used to study long-term viral persistence in Uganda and could be a vital tool in the search for an HIV cure that could target and eliminate this intact DNA reservoir.Last week, the US National Institutes of Health (NIH) announced the launch of a Phase 1 trial testing a nasal vaccine against COVID-19, the first trial conducted by NIH’s National Institute for Allergy and Infectious Diseases as part of Project NextGen, a US government initiative designed to advance the development of next-generation COVID-19 vaccines. In preclinical nonhuman primate studies, the candidate, MPV/S-2P, elicited a strong systemic immune response, as well as mucosal immunity, which plays an important role in controlling respiratory virus replication. Next-generation vaccines, including nasal vaccines, are a key tool needed to reduce COVID-19 infections and transmission as new variants of the virus continue to emerge.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last Thursday, Roche announced that its molecular Cobas HPV test received prequalification designations from the World Health Organization (WHO), a decision that will hopefully boost global efforts to eliminate cervical cancer through improved access to testing. The test received prequalification designations for use on the Cobas 5800 system and for self-collected samples on the Cobas 5800, 6800, and 8800 instruments, already having received WHO prequalification for use on the Cobas 6800 and 8800 systems last year. Prequalification will expand the availability of the test in many low- and middle-income countries that rely on prequalification to make regulatory, purchasing, and implementation decisions. Additionally, the use of self-collection, which was also recently approved by the US Food and Drug Administration, is expected to increase access to HPV testing by increasing comfort and ease for users.  The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) recently announced a $1 million award to Prompt Diagnostics to further the development of a portable, point-of-care platform to detect multiple pathogenic bacteria targets and their antibiotic susceptibility, an urgently needed technology to help address rising drug resistance globally. Rapid, sophisticated diagnostics can enable early detection of infections, more effective treatment management, and improved antimicrobial stewardship to help prevent the emergence and spread of drug resistance, particularly in low-resource settings where drug-resistant infections are particularly hard to treat and the burden of drug resistance is highest. Specifically, CARB-X hopes the platform will demonstrate feasibility for detecting gonorrhea infections in the face of disproportionately high rates of gonorrhea in low- and middle-income countries.New research shows that a novel genetic vector control technique is highly effective at reducing the population of Anopheles gambiae, the primary vector for malaria in Africa. The technology could eventually serve a crucial role in reducing malaria transmission, especially as conventional methods, including insecticide-based technologies and environmental controls, are becoming less effective due to insecticide resistance. The precision-guided sterile insect technique uses CRISPR, a gene-editing tool, to produce genetically modified highly sterile male mosquitoes that then mate with and sterilize female mosquitoes, leading to robust population suppression. Developers say that compared to other genetic modification technologies developed for this mosquito species, the new technique is safer, scalable, and confinable.